A Phase 4 interventional study of Ramelteon and Placebo in ADHD With Sleep Onset Insomnia, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-05-24.
Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Treatment
Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to placebo. Secondary:We expect that Ramelteon will show statistically significant improvements vs. placebo in measures of daytime sleepiness and with no decrement in daytime functioning, including such specific items as focus and social and occupational functioning.
Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in adult ADHD subjects who suffer from initial insomnia.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 32 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
8 mg tablets every night for 2 weeks, then a 2 week washout,then crossover to placebo tablets for 2 weeks.
Drug: Ramelteon
placebo tablets for every night for 2 weeks, then a 2 week washout, followed by 8 mg tablets every night for 2 weeks.
Drug: Placebo
8 mg tablets every night for 2 weeks
Also known as: Rozerem
placebo tablets for every night for 2 weeks
Change in Baseline to 2 Weeks ADHD Rating Scale
It is an 18 item scale with 9 symptoms of inattention and 9 symptoms of Impulsivity and Hyperactivity. This scale is the gold standard in assessment of ADHD. Scores range from 0-54. There must be a score of 6 or more in either category to be diagnosed with ADHD. Severity ranges: 6-18 mild, 19-36 moderate, 37-54 severe. The outcome measure is the percentage difference between the total day 1 score for all subjects and the total 14 day score for all subjects.
Time frame: day 1 to day 14 of study drug
Change in Clinical Global Impression (CGI)
The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). The outcome measure is the percent difference between the total score for all subjects at day 1 and the total score for all subjects at day 14 of the study drug.
Time frame: day 1 to day 14 of study drug
Subjects were screened by medical and psychiatric history after responding to solicitation with advertisements in local newspapers and from existing clinic populations.
| Milestone | Ramelteon Then Placebo (8 mg) | Placebo Then Ramelteon (8 mg) |
|---|---|---|
| Started | 16 | 16 |
| Completed | 16 | 16 |
| Not completed | 0 | 0 |
It is an 18 item scale with 9 symptoms of inattention and 9 symptoms of Impulsivity and Hyperactivity. This scale is the gold standard in assessment of ADHD. Scores range from 0-54. There must be a score of 6 or more in either category to be diagnosed with ADHD. Severity ranges: 6-18 mild, 19-36 moderate, 37-54 severe. The outcome measure is the percentage difference between the total day 1 score for all subjects and the total 14 day score for all subjects.
| percentage of change | Ramelteon | Placebo |
|---|---|---|
| Change in Baseline to 2 Weeks ADHD Rating Scale | 0 ± 0 | 0 ± 0 |
The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). The outcome measure is the percent difference between the total score for all subjects at day 1 and the total score for all subjects at day 14 of the study drug.
| percentage of change | Ramelteon | Placebo |
|---|---|---|
| Change in Clinical Global Impression (CGI) | 0 ± 0 | 0 ± 0 |
Collected over Length of study--average of 6 weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ramelteon Then Placebo (8 mg) | — | 0/16 (0%) | 3/16 (18.8%) |
| Placebo Then Ramelteon (8 mg) | — | 0/16 (0%) | 4/16 (25%) |
| Event | Ramelteon Then Placebo (8 mg) | Placebo Then Ramelteon (8 mg) |
|---|---|---|
| DrowsinessNervous system disorders | 2/16 | 3/16 |
| HivesSkin and subcutaneous tissue disorders | 1/16 | 0/16 |
| DizzinessNervous system disorders | 0/16 | 1/16 |
| Age, Categorical(Participants) | Ramelteon Then Placebo (8 mg) | Placebo Then Ramelteon (8 mg) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 16 | 32 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Ramelteon Then Placebo (8 mg) | Placebo Then Ramelteon (8 mg) | Total |
|---|---|---|---|
| Female | 9 | 6 | 15 |
| Male | 7 | 10 | 17 |
| Region of Enrollment(participants) | Ramelteon Then Placebo (8 mg) | Placebo Then Ramelteon (8 mg) | Total |
|---|---|---|---|
| United States | 16 | 16 | 32 |
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
University of Alabama at Birmingham